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NCT Number: NCT04914819

Postpartum Weight Loss for Women at Elevated Cardiovascular Risk

The aim of this study is to test the feasibility and effectiveness of a 16-week online behavioral weight loss program compared to usual care to promote weight loss in the postpartum period among women with cardiovascular risk factors. The investigators will also be testing different behavioral strategies to recruit postpartum women to the study, including 2 email recruitment strategies and 2 mailer recruitment strategies, informed by behavioral design.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus in Pregnancy Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Weight Gain Glucose Metabolism Disorders Hypertension Hypertension in Pregnancy Hypertension, Pregnancy-Induced Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Postpartum Weight Retention Pre-Eclampsia Preeclampsia Pregnancy Complications Recruitment Signs and Symptoms Urogenital Diseases Vascular Diseases Weight Gain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years;
  • Delivered a baby at HUP or PAH within 3-12 months prior to study start;
  • BMI ≥ 27 kg/m2
  • Diagnosis of one of the following medical conditions: chronic hypertension, gestational hypertension, preeclampsia, eclampsia, gestational diabetes, or diabetes mellitus (type 1 or 2) based on diagnosis codes in the EMR
  • Has online access through smartphone or computer and has email address
  • Ability to read and provide informed consent to participate in the study

Exclusion criteria

  • Delivered prior to 32 weeks gestation in the EMR
  • Documentation of fetal demise or neonatal demise in the EMR
  • Currently pregnant or planning to get pregnant within the next 5 months
  • Does not speak English
  • Answers yes to any of the following questions:
  • Are you currently participating in any other weight loss or physical activity studies?
  • Do you have any medical conditions or other reasons why you could not participate in a 16-week weight loss or physical activity program?
  • Participants will be excluded after completing the run-in period if they do not complete the daily food log or their baseline BMI is < 27 kg/m2

Treatment and study plan

Online Behavioral Weight Loss Program

Behavioral

Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.

Virtual weigh-in

Behavioral

Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.

Primary outcomes

  1. Change in Weight in Pounds From Baseline to 16-week Follow-up

    Time frame: Baseline and 16 weeks

    Mean change in weight in pounds from baseline to 16-week follow-up between study arms.

  2. Enrollment Rate Between Email Recruitment Strategies

    Time frame: 8 weeks

    We will compare enrollment rates between two behaviorally-framed email strategies

  3. Sign-up Rate Between Mailer Recruitment Strategies

    Time frame: 8 weeks

    We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift

  4. Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up

    Time frame: Baseline and 16 weeks

    Proportion of participants who lost 5 percent or more of their weight from baseline to 16-week follow-up between study groups.

Secondary outcomes

  1. Study Completion Rate Between 2 Arms

    Time frame: 16 weeks

    Proportion of participants that completed all follow-up procedures between both study arms.

  2. Intervention Arm: Number of Weeks With One or More Logins

    Time frame: 16 weeks

    Engagement with BWL platform measured by mean number of weeks with one or more logins

  3. Intervention Arm: Number of Weeks With Daily Data Reporting for at Least 5 of 7 Days

    Time frame: 16 weeks

    Mean number of weeks that calories, physical activity minutes, and body weight were reported at least 5 of 7 days

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Postpartum Weight Loss for Women at Elevated Cardiovascular Risk (EmPOWER-Mom Study)

Acronym: EMPOWER-Mom

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 7, 2021
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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